Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GC1008 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | Dose Group |
| Cohort B | EXPERIMENTAL | Dose Group |
| Cohort C | EXPERIMENTAL | Dose Group |
| Cohort D | EXPERIMENTAL | Dose Group |
| Cohort 1 | EXPERIMENTAL | Dose group |
| Cohort 2 | EXPERIMENTAL | Dose Group |
| Cohort 3 | EXPERIMENTAL | Dose Group |
| Cohort 4 | EXPERIMENTAL | Dose Group |
| Cohort 5 | EXPERIMENTAL | Dose Group |
| Name | Type | Description |
|---|---|---|
| GC1008 | BIOLOGICAL | 1 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days. |
Inclusion Criteria: * GFR≥25ml/min/1.73m2 calculated by the MDRD equation * Urinary total protein: creatinine ratios \>200mg/mmol derived from the average of 2 first morning voids taken during screening period * Biopsy confirmed as idiopathic FSGS by a central reviewer * Treatment resistance. NOTE:...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Apellis Pharmaceuticals, Inc. | APLS | 1 | PHASE2 | APL-2 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE2 | Frexalimab, Brivekimig, rilzabrutinib |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | Atrasentan |
| Akebia Therapeutics, Inc. | AKBA | 1 | PHASE2 | Praliciguat |
| Travere Therapeutics, Inc. | TVTX | 1 | PHASE2 | Sparsentan |
| Vera Therapeutics, Inc. Class A | VERA | 1 | PHASE2 | Atacicept |
GC1008 is an investigational monoclonal antibody being studied for Idiopathic Pulmonary Fibrosis (IPF) and Focal Segmental Glomerulosclerosis (FSGS). It has been evaluated in Phase 1 clinical trials for these conditions, though it is not approved and remains in clinical development.
GC1008 is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is responsible for the clinical development of this investigational monoclonal antibody.
GC1008 is in Phase 1 clinical development. It has completed Phase 1 trials for Idiopathic Pulmonary Fibrosis and Focal Segmental Glomerulosclerosis. As an investigational drug, it is not yet approved and is still undergoing clinical evaluation.
GC1008 has been studied in two completed Phase 1 trials: NCT00125385 for Idiopathic Pulmonary Fibrosis with 25 participants, and NCT00464321 for Focal Segmental Glomerulosclerosis with 16 participants. Both trials were conducted in multiple countries including the United States and European nations.
GC1008 is the primary name used for this investigational monoclonal antibody in clinical trials. No alternative names have been reported for this drug in the available clinical trial information.